Positive results from the EMERALD-3 Phase III trial showed AstraZeneca's Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE), demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, prior to TACE and then in combination with TACE thereafter.
These results will be presented today in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (abstract #LBA4000).
In a planned interim analysis, the STRIDE regimen combined with lenvatinib and TACE demonstrated a 30% reduction in the risk of disease progression or death versus TACE alone (based on a PFS hazard ratio [HR] of 0.70; 95% confidence interval [CI] 0.57-0.86; p=0.0007). The median PFS was 13.0 months for this regimen versus 9.8 months for TACE. The PFS improvement was broadly consistent across key prespecified patient subgroups.
For the secondary endpoint of overall survival (OS), a positive trend was observed in favour of the STRIDE regimen with lenvatinib and TACE versus TACE alone (HR 0.84; 95% CI 0.65-1.09; p=0.1814).
Although not formally tested at this analysis, the key secondary endpoints of PFS and OS for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed a clinically meaningful improvement in PFS (HR 0.71; 95% CI 0.56-0.91; nominal p=0.0062) and OS (HR 0.70; 95% CI 0.51-0.95; nominal p=0.0233) versus TACE alone. Median PFS was 12.9 months for STRIDE plus TACE versus 8.1 months for TACE alone.
In a pre-planned exploratory analysis comparing the two investigational arms, a PFS improvement was observed favouring the lenvatinib-containing arm in patients with non-viral aetiology (HR 0.70; 95% CI: 0.44-1.09). The trial will continue to assess OS and other key secondary endpoints in both investigational arms.
Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial said, "Patients with embolisation-eligible liver cancer face the burden of repeated localised therapy and are in urgent need of new systemic treatment options to delay disease progression and recurrence. The EMERALD-3 trial represents a meaningful advance for patients, with nearly one in three alive and progression-free at two years when treated with this dual immunotherapy regimen with or without lenvatinib, with a trend toward improved survival."
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Building on practice-changing results from the HIMALAYA Phase III trial, these progression-free survival results and the early overall survival trend in the EMERALD-3 trial highlight the meaningful impact of bringing the STRIDE regimen into an earlier setting. These results advance our strategy to move novel immunotherapy regimens into earlier stages of cancer and underscore the opportunity to bring new treatment options for patients into this challenging liver cancer setting."
The safety profile for each combination was consistent with the known profiles of each medicine. Grade 3 or higher adverse events from all causes occurred in 71.4% of the patients in the STRIDE plus lenvatinib and TACE arm, and 64% of the patients in the STRIDE plus TACE arm, versus 28.6% in the TACE-only arm.
Summary of PFS and OS results: EMERALD-3
STRIDE + lenvatinib + TACE (n=293) |
TACE (n=292) |
STRIDE + TACE (n=175) |
ACE (n=first 175) |
||
|---|---|---|---|---|---|
| PFS | |||||
Number of patients with event (%) |
STRIDE + lenvatinib + TACE (n=293) 172 (58.7) |
TACE (n=292) 201 (68.8) |
STRIDE + TACE (n=175) 123 (70.3) |
ACE (n=first 175) 140 (80.0) |
|
Median PFS (in months) |
STRIDE + lenvatinib + TACE (n=293) 13.0 (12.2-16.7) i,ii |
TACE (n=292) 9.8 (8.0-11.4) i,ii |
STRIDE + TACE (n=175) 12.9 (10.2-15.9) iii,iv |
ACE (n=first 175) 8.1 (6.5-10.2) iii,iv |
|
HR (95% CI) |
STRIDE + lenvatinib + TACE (n=293) 0.70 (0.57-0.86) i |
TACE (n=292) 0.71 (0.56-0.91) iii, iv |
|||
P-value |
STRIDE + lenvatinib + TACE (n=293) 0.0007 v |
TACE (n=292) 0.0062 vi |
|||
Data maturity |
STRIDE + lenvatinib + TACE (n=293) 63.8% i |
TACE (n=292) 75.1% iii |
|||
PFS rate at 12 months (%) |
STRIDE + lenvatinib + TACE (n=293) 56.2 |
TACE (n=292) 42.9 |
STRIDE + TACE (n=175) 53.0 |
ACE (n=first 175) 38.0 |
|
PFS rate at 18 months (%) |
STRIDE + lenvatinib + TACE (n=293) 42.1 |
TACE (n=292) 30.8 |
STRIDE + TACE (n=175) 38.8 |
ACE (n=first 175) 29.8 |
|
PFS rate at 24 months (%) |
STRIDE + lenvatinib + TACE (n=293) 30.4 |
TACE (n=292) 19.3 |
STRIDE + TACE (n=175) 30.0 |
ACE (n=first 175) 20.3 |
|
| OS | |||||
HR (95% CI) iii |
STRIDE + lenvatinib + TACE (n=293) 0.84 (0.65-1.09) |
TACE (n=292) 0.70 (0.51-0.95) iv, vii |
|||
P-value |
STRIDE + lenvatinib + TACE (n=293) 0.1814 v |
TACE (n=292) 0.0233 vi |
|||
Median OS (in months) iii |
STRIDE + lenvatinib + TACE (n=293) 39.5 (34.1-NC) |
TACE (n=292) 34.7 (28.8-NC) |
STRIDE + TACE (n=175) NC (37.7-NC) iv, viii |
ACE (n=first 175) 32.9 (24.1-43.2) |
|
Data maturity iii |
STRIDE + lenvatinib + TACE (n=293) 40.3% |
TACE (n=292) 45.4% |
|||
OS rate at 12 months (%) iii |
STRIDE + lenvatinib + TACE (n=293) 83.2 |
TACE (n=292) 82.0 |
STRIDE + TACE (n=175) 87.7 |
ACE (n=first 175) 81.5 |
|
OS rate at 18 months (%) iii |
STRIDE + lenvatinib + TACE (n=293) 77.5 |
TACE (n=292) 69.7 |
STRIDE + TACE (n=175) 76.4 |
ACE (n=first 175) 67.3 |
|
OS rate at 24 months (%) iii |
STRIDE + lenvatinib + TACE (n=293) 66.9 |
TACE (n=292) 61.5 |
STRIDE + TACE (n=175) 68.0 |
ACE (n=first 175) 57.8 |
|
NC, not calculable i The data cut-off date was 02 Sep 2025 ii PFS was assessed by BICR per RECIST v1.1 iii The data cut-off date was 23 Feb 2026 iv Descriptive per the pre-specified multiplicity/hierarchy; no formal statistical inference is claimed v Stratified log rank vi Nominal vii Estimated using a stratified Cox proportional hazards model viii Calculated using the Kaplan-Meier technique; CI derived based on Brookmeyer-Crowley method |
|||||
Notes
Liver cancer
Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death.1-2 In 2026, more than 200,000 patients will be diagnosed with embolisation-eligible HCC, with more than 180,000 in China and Japan alone.3 Embolisation is a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.4-5
Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings, including STRIDE.2
EMERALD-3
EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial of a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks (STRIDE regimen) plus TACE with or without lenvatinib versus TACE alone in a total of 760 patients with unresectable HCC eligible for embolisation.
Participants were randomised in a 1:1:1 ratio to Arm A (TACE, Imfinzi, Imjudo, lenvatinib), Arm B (TACE, Imfinzi, Imjudo) and Arm C (TACE) until each arm reached 175 participants. Randomisation was then continued in a 1:1 ratio to treatment Arms A and C until each reached approximately 275 participants. Patients received Imfinzi with Imjudo, plus TACE as needed, with or without lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until progression.
The trial was conducted in 171 centres across 22 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS for Imfinzi plus Imjudo, lenvatinib and TACE versus TACE alone. Secondary endpoints include OS for Imfinzi plus Imjudo, lenvatinib and TACE, and PFS and OS for Imfinzi plus Imjudo and TACE versus TACE alone.
Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
In gastrointestinal (GI) cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. In resectable gastric and gastroesophageal junction (GEJ) cancers, perioperative Imfinzi added to standard-of-care chemotherapy is approved in the US and EU.
In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.
Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC) based on results from the NIAGARA Phase III trial. Imfinzi is also approved in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in the US and Brazil for BCG-naïve, high-risk non-muscle-invasive bladder cancer based on the POTOMAC Phase III trial. In May 2026, perioperative Imfinzi with or without Imjudo plus neoadjuvant enfortumab vedotin (EV) met its dual primary endpoint of PFS for both regimens, treating patients with cisplatin-ineligible MIBC in the VOLGA Phase III trial. Perioperative Imfinzi plus neoadjuvant EV also achieved a significant OS benefit, a key secondary endpoint.
Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.
Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers.
Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across multiple tumour types including in SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.6
Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers.
Imfinzi, an anti-PDL1 antibody, is approved in combination with chemotherapy in locally advanced or metastatic BTC and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Imfinzi is being assessed in combinations, including with Imjudo, in liver, BTC, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.
Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Lynparza, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).
The Company is also assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without Imjudo as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. Rilvegostomig is also being evaluated in combination with Enhertu in previously untreated, HER2-expressing, locally advanced or metastatic BTC.
AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD4360, an ADC, currently being evaluated in a Phase I/II trial in patients with advanced solid tumours.
In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3) armoured CAR T, in HCC.
AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body's immune system to attack tumours.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide.
